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프린트
전체 257건, 현재 페이지 7/26
GPKOL
GMP
브라질
- 브라질 PDP(Productive Development Partnership) 프로그램 기술이전(TT) 매니지먼트 - 기술이전 관련 품질관리 파트 컨설팅 - 약물 stability test, forced degradation test 관련 컨설팅 - 약물개발 및 밸리데이션
R & D기획
미국
- 초기 물질 발굴(의약화학) - 최적화 프로그램 의사결정, SAR 개발, 전임상 후보물질 합성 - 후보물질에 대한 임상시험 진행 등
인허가
인도
Strategic regulatory affairs professional with 19 years of global and regional experience in regulatory affairs (Category + CMC), regulatory compliance of pharmaceutical products – generics (Rx) & consumer healthcare products (OTC medicines including Ayurvedic). Worked for world top 5 pharmaceutical / consumer healthcare MNCs companies in SINGAPORE & INDIA. Abhishek has successfully led leadership roles with global pharma and healthcare MNCs in Singapore & India. Abhishek has an outstanding track record for the followings. - Leading global and regional regulatory registration filing for European Union EU, Rest of world (ROW), Asia-Pacific, India, Middle east & Africa - Leading global product life-cycle management (LCM) license renewal, variation filing / post approval change, commercial initiative, health authorities’ commitments, regulatory compliance & geographical expansion of generics and OTC products - Establishing regulatory compliant system & process (SOP, working instructions, best practice guide) - Managing FDA plant audits like US FDA, MHRA, ANVISA, TGA, GCC, NAFDAC and health authority (HA) interactions. - Establishing regulatory repository / database, trackwise & quality systems. Abhishek also has regulatory articles publication in RAPS (Regulatory Affairs Professional Society, USA) which are under top 10 read article worldwide and author of regulatory course on Udemy (Introduction to European medicine marketing authorization)
임상
- 임상 통계 컨설팅, 임상시험 Ⅰ/Ⅱ/Ⅲ 상 설계 디자인 및 프로토콜 작성 - 표본수 및 검증력 계산, 데이터 분석 계획 및 분석 결과 해석 - 미국 CRO 선정 및 관리 - CDISC (SDTM, ADaM)전문가 - 항암 스터디 설계 및 분석 전문
인허가 R & D기획
[Regulatory Science] - Regulatory principles and procedures regarding IND, NDA, BLA for developing drug candidates [Trial Design/R&D strategy(Clinical Pharmacology] - Translational science utilizing pharmacokinetics and pharmacodynamics data to predict clinical efficacy and safety [Trial Design/R&D strategy(Modeling and simulation)] - Population approach to pharmacokinetics/pharmacodynamics data - Statistical/mechanistic analysis and modeling to predict clinical efficacy and safety
1. 미국 임상 시험 시장 동향 및 시장 진입 전략 2. Phase Ⅰ/Ⅱ/Ⅲ 임상시험 데이터 관리 3. Full package 임상시험 관리 시스템 (EDC/Clinical Trial Management System) 설계 및 개발 4. 임상시험 모니터링 (risk-based monitoring, central statistical monitoring, remote monitoring), FDA regulatory compliance/cIRB package, clinical trial network (consortium) infrastructure management, 무작위 배정 (minimal sufficient balancing method, response adaptive randomization 등 최신 알고리즘 구현), 데이터 분석 (SAS, R, Python) 시스템 내재화 등 최신 임상시험 운영/관리 기술 시스템화 5. 대규모 다국가 3상 임상시험 프로젝트 관리 및 Auditing
인허가 PM
칠레
Profesional with more than 20 years experience on the chilean public health industry which cover the 80% of the chilean population. - Regulatory Affairs: Extensive experience on Local Regulatory Affairs, evaluation and registration of new products (Drugs and Medical Supplyes) and pricing study for new products. Acces to high health chilean authorities. - Project Management: High knowledge of the public and private health market processes for the introduction of new companies and new products on the local market with strong contac with key managers on public and private sector . Capacity for collecting data, detailed follow up and data output analisys for decisión making.
R & D기획 기술마케팅
스위스
1. Pharmaceuticals(Biotech & Pharma): R&D Planning, R&D Strategy, Portfolio Prioritization - Strategic Analysis of scientific opportunities in (Bio)Pharmaceuticals - The Commercialization of Science: º Smart Development Strategy following clinical Proof of Concept º R&D Portfolio Prioritization º Partnering: in-and out- licensing of development compounds - Innovation Management: º Aligning R&D with Regulatory Requirements, Market Needs and Opportunities º Capturing fundamental and incremental innovation opportunities 2. Pharmaceuticals(Biotech & Pharma): Market Access Strategy, Commercialization - Market Access; value-based pricing & reimbursement strategies - Global Launch Excellence: Go to Market Strategies, Global commercial roll-out - Commercialization; medical / regulatory / market access / marketing / sales / key account management / digitalization opportunities - Life Cycle Management: strategies to extend the productive life cycle of (bio)pharmaceutical products - Partnering: in- and out- licensing of (bio)pharmaceutical products
(R&D Planning) Disease selection, Target ID/validation, Target commitment (Technology) Functional genomics tools, target modality/tractability assessment
- Clinical Development Business Alliances, and Licensing - Commercialization and New Product Launch - Oncology & Pharmaceuticals - Consumer Beverages
